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An open-label, prospective, controlled, two-step approach, post-marketing clinical study, applying DermaStream with saline streaming, in conjunction with a sustained multi-compression wrap, on healthy individuals and on patients with a venous stasis ulcer of the lower extremity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dermastream | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DermaStream | Device | Five treatment days. On each day DermaStream application for up to 4 hours of saline streaming. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of DermaStream application | Reduction of slough tissue. | Up to 21 days |
| Adverse Events | Incidence of investigational product related adverse events | Up to 21 days |
| Effect of DermaStream application | Increase of granulation tissue | Up to 21 days |
| Effect of DermaStream application | Pain recording on 1-10 scale | Up to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Usability | Device malfunction reports and device replacements as measures of usability | 1-5 days |
| Wound size | Decrease in wound size at 2 weeks following last treatment day |
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Inclusion Criteria:
Group A:
Group B:
Exclusion Criteria:
Group A and Group B:
Group B:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Ihnat | S.A.L.S.A, Tucson Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| S.A.L.S.A | Tucson | Arizona | 85724 | United States |
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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| Up to 21 days |
| Quality of Life | Improved "Quality of Life" at 2 weeks following last treatment day | Up to 21 days |
| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |